Status:
UNKNOWN
Surveillance of Association of Immune Status and Prognosis of CNS Germ Cell Tumor Survivors
Lead Sponsor:
Chengcheng Guo
Conditions:
Intracranial Germ Cell Tumor
Intracranial Germ Cell CNS Tumor, Childhood
Eligibility:
All Genders
Brief Summary
Platinum-based chemotherapy, alternating at 21-days intervals with cycles of ifosfamide, cisplatin, and etoposide (ICE) and subsequently received radiotherapy were considered as standard treatment for...
Detailed Description
Immune status influences the reaction of anti-tumor and health condition of intracranial germ cell tumor patients. Peripheral blood and cerebrospinal fluid lymphocytes subsets, cytokines reflects thos...
Eligibility Criteria
Inclusion
- Primary diagnosis of an intracranial germ cell tumor (Histologically confirmed intracranial non-germinomatous or germinoma germ cell tumor).
- Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm.
- No history of anti-tumor treatment
- Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
- Be willing and able to provide written informed consent/assent for the trial
Exclusion
- Patients with immune function deficiency : immunosuppression status, including autoimmune disease, post-operation of organ transplantation, in-taking immunosuppressive drug, human immunodeficiency virus (HIV) positive patients,
- Known history of active tuberculosis not adequately treated or positive QuantiFERON TB Gold test.
- Hypoproteinemia (eg, in case of severe liver disease or nephrotic syndrome) with serum albumin \<3.0 g/dL.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04909307
Start Date
June 1 2019
End Date
December 31 2023
Last Update
June 3 2021
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China